ClearPath DS-120 Clinical Study Protocol

Completed

Conditions studied: Ophthalmic, Healthy Eyes

In brief

The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.

Key facts

Study ID

NCT01425346

Run by

Freedom Meditech

People needed

128

Starts

2011-06-01

Expected to finish

2011-07-01

Last updated by the study team

2011-08-30

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
• Subject must be able to read or understand and give informed consent.
• Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of <20/40.

You may not qualify if…

• Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
• Subject has been clinically diagnosed with cataracts in the study eye.
• Subject has had a fluorescence angiogram within the last six months.
• Subject has undergone a treatment using photodynamic drugs within the last year.
• Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
• Subject was fit with contact lens within the last 30 days.
• Subject has ocular surface (dry eye) disease.
• Subject is unable to cooperate with or understand clinical instructions.
• Subject is unable to complete test sequence

Where it is running

• San Diego Optometry Practice — San Diego, California, United States

Full record on ClinicalTrials.gov

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